Manufacturing Problems at Triad Alcohol Prep Pad Plant Known in July 2009

Documents have surfaced that indicate federal regulators have known for 18 months about problems with sterilization and manufacturing practices at the plant where millions of recently recalled Triad alcohol prep pads were made. 

Triad Group issued an alcohol prep pad recall in early January 2011, after it was discovered that tens of millions of prep pads, swabs and swabsticks tainted with the bacteria Bacillus cereus may have been distributed to consumers.

The alcohol prep pads and wipes were commonly used in hospitals and packaged with a number of medications. They were sold under the Triad brand name, as well as under a variety of other labels, including CVS, Walgreens and Cardinal Health.

According to an MSNBC report, FDA inspectors raised concerns as early as July 2009 about sterilization techniques at the same Hartland, Wisconsin production facility where the alcohol prep pads were made. Despite reports from FDA investigators that indicate the company was not following proper sterilization procedures, no warning letters or official citations were issued. 

Since the Triad recall was announced, the FDA has received at least 100 additional reports from consumers who have had problems with the alcohol prep pads and wipes. Bacillus cereus on the alcohol prep pads could cause skin infection, or if the bacteria is pushed into the skin after the surface is cleaned with one of the wipes, it could result in potentially life-threatening infection.

At least two Triad alcohol prep pad lawsuits have been filed in recent weeks; one by the parents of a two-year-old Houston boy who died due to a Bacillus cereus infection, and another by a Tennessee man who alleges that a Triad alcohol prep pad infection left him permanently disabled.

Documents obtained by MSNBC show that FDA inspectors made repeated visits to Triad facilities prior to the recall, finding that the company could not validate its sterilization process for alcohol prep pads, swab sticks, wipes, lubricating jelly, hemorrhoid creams, suppositories and other products. The inspectors found that there was no validation of the gamma radiation sterilization process and they also discovered that Triad had knowingly shipped out products that failed to meet specifications.

Last week, Triad recalled 18 lots of sterile lubricating jelly due to concerns that it was not sterile. FDA inspectors said that in January the jelly failed viscosity tests, but was cleared for distribution by Triad President David Haertle. The decision was rescinded a week later, but not before some of the jelly had been shipped out.

In addition to quality control problems, inspectors also found a number of complaints to Triad that the company had failed to pass on to the FDA, including reports from hospitals regarding abnormal pap smear results caused by the jelly and reports from more than 30 women who suffered vaginal irritation after having the jelly applied during examinations.

Last month the FDA launched an investigation into the circumstances of the Triad alcohol prep pad recall. As recently as January 7, FDA inspectors found problems at the Triad plant.